Ibuprofen and the fertile imagination

There is an astounding variety of painkillers available for purchase both in supermarkets, chemists, and corner shops. Just take a look at the shelf of your nearest Tesco or Sainsbury. You have various types of paracetamol, both made by pharmaceutical companies as well as in house versions of the supermarkets.

What is the difference between them and why are there so many varieties?

When pharmaceutical companies take on the decision to manufacture a new drug, they are given a twenty-year patent which covers the research into the product, testing and manufacturing, and sales. The period of twenty years, a monopoly as such, is to reward them for the time invested into the research. In the course of the research into the product, pharmaceutical companies must publish various forms of medical evidence and put it into public domain, so that if there is any medical evidence that points to the contrary, these can be debated both by the medical community and the pharmaceutical world.

The problem, if we can call it that, is that business is a very competitive world, and if research is put out in the open without any form of intellectual protection, any manufacturer can pounce on the research undertaken by someone else who has taken the effort and trouble to do it, and produce their product off the back of it. They would have saved the time and cost investment.

Imagine if a writer has taken the time to research a topic, organise his thoughts succinctly, and find a publisher. And when his book is published, someone else photocopies it, binds the copied pages and subsequently peddles it as their own.

Within the period of twenty years, a pharmaceutical company has to research, market and sell enough of the product to recoup the investment costs and profit. It is after the twenty period has expired that the other sharks enter the fray. This is where you get the supermarket brands of the product, which are cheaper because they don’t need to pay for research.

What is the difference between brand names and generics? They essentially do the same thing. But if the original company has done a good job in making the product synonymous with its own brand, then you might think they are better. If you take Neurofen for headaches, then you might think it better than Tesco ibuprofen, even though they both contain the same active ingredient.

But pharmaceutical companies have to reinvent themselves, to make varieties of the same product, otherwise they will lose their market share and eventually die out. If you realise that Neurofen is matched in ability by the cheaper Tesco ibuprofen, you would buy the latter, unless you are persuaded that Neurofen for Flus and Colds, or Neurofen Muscle Pain has something clinically formulated for that specific purpose.

So the shelves of supermarkets are stacked with different priced products with the same active ingredient, as well as different varieties of the same product.

Painkillers are a common medicine because there will always be a demand for pain management.

The availability of pain relief medicine means it is easy for the average individual to obtain them. There is the possibility of overdose, and while this may be a rarity, there is a higher likelihood that the greater availability may mean individuals are taking more doses than they should.

What are the long term health impacts of taking ibuprofen for prolonged periods?

One problem is that the body adapts and so the long-term resistance is affected. In certain groups such as the elderly, aspirin also increased the risks of stomach bleeding.

A clinical trial seemed to suggest it may impact on testosterone production and hence affect fertility.

Test subjects were administered 2 x 600mg doses of ibuprofen daily for six weeks, much higher than the average dose. The sample size was only a small group of 30, and half received ibuprofen, while the others received a placebo. It would have been better if the subject group had been greater, so that there could be more confidence in the test results, but because a test of such nature is to examine human resistance to what is essentially toxicity, it would have been unethical to involve a large group of participants. The research findings found that there was no impact on testosterone already in the body, but the pain relieving nature of ibuprofen, as a relaxant of sorts, had impact on the production of testosterone and appeared to slow down production.

How did these reports end up in the media? The tabloids had a field day, and you would undoubtedly have found one with the usual wisecracks about balls and other man-related genitalia, along the lines of “Ibuprofen shrinks your balls” or “Ibuprofen smalls your balls”.

Maybe instead of Ibuprofen for colds or fast relief, we need Ibuprofen for Dummies.

What your breakfast reveals about media companies

Wordsmiths would tell you that the origins of the word “breakfast” lie in the words “break” and “fast”. Then again, you wouldn’t actually need an expert to tell you the combined word comes from its intention – to end the fasting period. What fast? Presumably in Roman days the fast represented the period from after sunset to sunrise, where people had to endure going without food in the cold of night, at a time when the thinking was “Eat as much as you can during the day, while you can”. The line of thinking about what to eat for breakfast certainly does vary from place to place. Some believe that after a period of doing without food – okay, so a few hours every evening now after a “Just Eat” gorge of Indian takeaway washed down with bottles of Kingfisher can hardly be called a fast anymore –  the body has to stock up on its resources. Enter the full English breakfast; sausages, bacon, eggs, tomatoes, beans (mustn’t forget your greens), black pudding – everything you wanted to eat during the day, presented to you literally on a plate, in case you miss the opportunity to eat later on. In contrast, there are others of the thinking that after an overnight period of doing without, the body cannot be forced into what is a gorge. Just as someone who is parched and dehydrated has to resist the natural urge to guzzle down water when presented with it, breakfast, some think, is only a primer for a heavy lunch. Hence the idea of a light continental croissant, a little way of appeasing the hungry body but regulating the intake of food so the body is not lulled into a yo-yo pattern of starvation and gorging that is more typical of eating disorders.

Makes sense? Both points of view actually do, despite the conflicts about whether or not to eat heavy first thing in the morning. But to further complicate the issue, a third group believes that since your body, when at rest, will require resources to draw on when you are asleep, then it makes perfect sense to load up with a heavy meal as the last meal of the day. Start light, finish heavy. Viewed in the context, it makes sense too.

If there is any one consistent factor about diet, it is probably that the debate, ideas and media reports will continue into the future, and ideas will come and go and come back again. The fad for various diets has sold books and filled magazine columns and given the media lots to write about, which is great for the industry because media is not a sector that relies on bringing to you information that is necessarily correct, it is a sector that relies on attracting readership and human traffic in order to build up a reader base which it leverages to companies to sell advertising. Advertising is what drives media, not the exposition or exploration of facts. Hence media companies will present information that they feel is of interest and will hook in readers. It doesn’t necessarily have to be substantiated, as long as there is a fellow source to mention, as if the validation of facts had been corroborated by them.

Where do research scientists fit in this grand scheme of things? There are various kinds of research scientists, ones that truly explore the world in order to further it, and others who conduct investigation in order that it may be latched on to by the media in reports. Ultimately it comes down to who is funding the work. Funded by a company such as Cancer Research? The investigative research conducted by such research scientists is likely to be subject to stringer validation. Funded by a pharmaceutical company? The data obtained by such research needs to be handled carefully in order that the outcomes are not flawed or biased towards any products the company is producing.

In other words, if a pharmaceutical company is working on producing a medical product that is, for example, has seaweed as an active ingredient, then the research must not be conducted in a way that only shows the positive benefits of seaweed; research that only gives supposed scientific validation to a pre-determined result.

Bias is all too easy to spot when the links are direct, when a pharmaceutical company employs scientists. But what happens when the grand paymaster is the media company?

Hang on, I hear you say. Why would a media company, perhaps a newspaper, employ a group of scientists? And how could they get away with it?

The end product for a pharmaceutical company is a medical one. The end product for a newspaper is news, and the research scientists are there to provide it.

The group of scientists don’t necessarily need to be under permanent employ, just occasional contract work when there are lull periods in the news. And the work that they do is not necessarily related to what is in the article that is published anyway. Tenuous links are exploited to maximise the draw of a headline.

This is how it works:

A shark is a fish. A whale is a fish. Your newspaper reports that there is the possibility that sharks could become whales.

And that’s it.

A media company – newspaper, magazine, channel, web agency – can hire research scientists to lend credibility to semi-extravagant claims.

As long as there is another attributable source, or somewhere to dismiss the evidence – easily done by mentioning “It is generally accepted that …” or “Common convention holds that …” before launching into the juicy bit – the bit that spins things out, through a long process by which the receiver, either reader or viewer, has hopefully forgotten what the gist of the argument was in the first place – everything can passed off. In fact, it is a psychological trick – the receiver keeps following in the hope of being able mentally ordering the great influx of information.

Ever watched a BBC drama series? After six episodes, numerous disjointed flashbacks, the final  episode always seems a bit of a letdown because you realise everything was obvious and the in-betweens were just filler bits to spin things out.

I digress. But returning to the point, media companies can hire research scientists on an occasional basis. Some may even do so, and have a scientist for full time hire as a generator of scientific news.

A direct link between a media agency and a research scientist may sound implausible. But think of the UK’s Channel 4 programme, Embarrassing Bodies, where a team of four doctors go around examining people, dispensing advice, running health experiments in a format of an hour-long slot punctuated by two minutes of advertisements for every thirteen minutes of the programme.

If the media company does not want its links to be so obvious, it can dilute them progressively through the form of intermediary companies.

For example, ABC newspaper hires DEF company to manage its search engine optimisation campaign. DEF hires GHI creative media, who hire  JKL, a freelance journalist who knows Dr MNO, who conducts research for hire. Eventually MNO’s “research” ends up in the ABC newspaper. If it proves to be highly controversial or toxic to some extent, ABC’s links to MNO are very, very easy to disavow.

So when the media recently reported that scientists say skipping the morning meal could be linked to poorer cardiovascular health, should we pay any heed to it?

The research findings revealed that, compared with those who had an energy-dense breakfast, those who missed the meal had a greater extent of the early stages of atherosclerosis – a buildup of fatty material inside the arteries.

But the link been skipping breakfast and cardiovascular health is tenuous at best, as the articles themselves admit.

“People who skip breakfast, not only do they eat late and in an odd fashion, but [they also] have a poor lifestyle,” said Valentin Fuster, co-author of the research and director of Mount Sinai Heart in New York and the Madrid-based cardiovascular research institute, the CNIC.

So a poorer lifestyle gives negative impact to your health. A poorer lifestyle causes you to miss breakfast. Sharks do become whales.

This supposed link between skipping breakfast and cardiovascular health was published in the Journal of the American College of Cardiology, and the research had partly been funded by the Spanish bank Santander. The health and diets of 4,052 middle-aged bank workers, both men and women, with no previous history of cardiovascular disease were compared.

You can bet that on another day where news is slow, someone will roll out an “Eating breakfast on the move harms your health” headline. Nothing to do with the way you move and eat, it is simply because you have a stressful lifestyle that impacts on your health which forces you to eat on the go. But it was a link and headline, a “sell” or bait that drew you in to either purchase a newspaper or magazine, watch a programme, or spend some dwell time on a site.

And that’s how media works.

Medicines: Brand Names and Generics

William Shakespeare once wrote that “A rose by any other name is still a rose.” And in the pharmaceutical world it is a common occurrence to see that the same medicine can be called by different names. This can prove to be confusing.

Many medicines have two names. The first is the scientific name to the medicine itself – an expert committee decides the generic or common name for it, named for the active ingredient itself. For example, erectile dysfunction is treated by a medicine containing sildenafil, which is a generic name.

The same medicine also has a second name, the brand name. For example, sildenafil is more commonly known by its brand name, Viagra. Pfizer, the company that produces it, has chosen to market it under this name because brand names are more memorable than scientific names, especially at the onset when new products have just been launched. Can you imagine someone going to the pharmacist and asking for the “Silder .. silver … cyber … you know, the thing that gives more bounce and keeps going for longer?”

“Red Bull? Duracell?”

You get the idea.

The company that produces a new medical product is usually granted a patent. This patent grants the company exclusive rights to the product for a standard period usually of twenty years, and allows the company to recoup the investment spent on the development on the drug as well as to financially benefit from sales during the patent period.

While twenty years may seem like an extraordinary amount of time, it is actually not so. Most companies apply for the patent at the initial stages at development, to avoid the situation of being trumped by another company after they have done a few years of research. Imagine you have done five years of research and when you are about to proceed further, someone has applied for a patent for a product that effectively nullifies the work you have done. Or what is worse, they may even draw on your research from various medical publications to further the development of their own product. The time you have spent has been wasted and your intellectual property has been stolen.

The first ten to fifteen years of a patent are hence a covering period for the research into it and to cover the licensing process while the remaining period is the time the company has to solely market the product using as brand name, so that it becomes memorable and commandeers a huge market share after the patent period has expired.

Once the patent protection expires, other companies can produce their own version of the medicine. Hence, pharmaceutical companies are always engaged in a race against time. They have a twenty-year period to research, license, market and profit from their product before the other sharks enter the fray, so to speak.

Take for example, ibuprofen, the medicine commonly used to treat pain and inflammation. There are many branded versions of ibuprofen, such as Nurofen and Hedex. Various supermaket chains distribute their own versions as well, but under the common scientific name. You have Tesco’s ibuprofen or Superdrug’s ibuprofen. We can assume that once a product (such as Neurofen) reaches the mass market, and has been quoted enough times as to “contain ibuprofen”, the scientific name itself becomes somewhat of a brand in its own right.

Having various versions of the same medicine is confusing, but depending on our loyalty we may opt for Neurofen because it is the established brand we know. This of course depends on how it has been marketed; if the pharmaceutical company has done enough advertising to convince us that “Neurofen”, and not “Ibuprofen” is the key to pain-relief, then by association we may go for Neurofen whenever we have a headache. If cost is a more significant factor than loyalty, then we might go for the generic medicines because they are usually cheaper – they have had fewer research and development costs, but they contain the same active ingredient as the branded products.

In some cases latter companies may have simply waited for the patent to lapse, before moving in to reverse-engineer their own version of the product and market it. This is especially true for products that people will always have a need for, such as products offering relief from pain, flu, or colds; or balms of various descriptions.

Generic medicines go through the same detailed safety and quality requirements as the original branded product, but because the significant outlay of research costs have been avoided (the initial company has done the hard work) the latter products are cheaper.

Supermarket chains are already flooded with many versions of the same product. Look at your supermarket chain – how many brands of ibuprofen do they stock? This begs the question of whether chains will eventually simply stick with the products with a big market share (and hence likelihood of sale), stock more cheaper options, or even offer cheaper, newer brands. It is likely that they will do a combination of the first two. New and cheaper brands will find it hard to penetrate the market based on cost alone, as the cost of advertising is too huge. The only way they can hold on to a significant market share is if one of the bigger brands declines, perhaps through negative publicity, and one of the new brands promotes itself by aligning itself with a social cause.

Imagine, for example, there is a medicine called Increasil (scientific name) produced under the brand name Livealongerlife by parent company Healthpharm. Liveralongerlife claims to prolong the life of the terminally-ill and extend their high-functioning years by delaying the onset of infections. After it has been doing well for a few years, towards the end of its patent, it is discovered that Healthpharm conducted unethical drug trials – they tested liquid versions of Increasil by injecting them into corpses to see if it would slow the rate of decay.

Amidst the media storm, the company Fitness21 prepares to produce its own version of Increasil under the brand name Newtrition. They reverse-engineer batches of Increasil, and benefit from the research Healthpharm had previously done. As part of its submission evidence into the safety of Increasil, Fitness21 conducts trials on aging volunteers to see if they experience any increased life expectancy. The evidence gathered by Fitness 21, and also the perceived benefit of Increasil (while it was sold by Healthpharm), contributes to Fitness21 gaining a license to market Increasil in the form of Newtrition.

Fitness21 builds its factories in the impoverished third-world town of Valhalla, promising to regenerate the area. The people of the town benefit from employment, and Fitness21 sells Newtrition to its own employees at a vastly discounted rate, announcing that it hopes to raise the life expectancy of Valhalla from 50 to 75 within two decades, and in doing so, allowing the citizens to have a longer working life and more wealth, with the aim of lifting the town out of its doldrums. Future generations will benefit and the children and grandchildren of those now of working age will have very different futures from their forefathers. Fitness21 announces that its employees are like family, and it has an interest both in elevating their working and life conditions, and the fact that it is distributing Newtrition to its own employees means it has an obligation in ensuring the product itself is of the highest quality. Fitness21 is strongly interwoven and ingrained in the social fabric from which Newtrition is produced.

Whose version of Increasil would you buy? Probably the latter’s. And that is probably the only way for unestablished brands to forge through a packed market, by leveraging on social and ethical links. We have seen various products – not just medicines – marketed using that angle. Do the words Fairtrade and Co-Op sound familiar?

Prescribers (people who prescribe medicines, such as GPs) are encouraged to prescribe medicines by their generic name, not only because it is ethically right to prescribe the medicine costing less if the results are similar – and generic brands can cost significantly less – but also because it gives the pharmacist the widest choice of products to dispense, which can be important, particularly if there is a shortage of a particular product.

If you are switched from a particular brand to a generic, it is standard practice for your pharmacist to explain the changes to you, in terms of side effects, and to address any concerns you may have. In fact, this is not just if you switch brands – whenever you have changes in medication you should always speak to your pharmacist.

Only in rare cases it is important for a patient to stay on the branded medicine previously prescribed for them, rather than changing to a generic medicine. This is usually because of the way the medicine acts on the body.

Some examples of when you should keep taking your brand of prescribed medicine include:

Epilepsy medicines – these should be treated with care because different versions may have slight differences in the way they are absorbed, which can cause big differences in their effect. For example, prescribers may decide the branded version of lamotrigine (Lamictal) is more suitable than the generic version.

Modified-release preparations of medicines – such as modified-release versions of theophylline, nifedipine, diltiazem and verapamil. A branded version may sometimes be a better option than the generic equivalent, as they can be absorbed differently, and suited differently to various individuals.

Biological medicines – these complex medicines are derived from proteins and other substances produced by the body. Copies of biological medicines, called biosimilars, can never be exactly the same so shouldn’t be automatically used as substitutes. Doctors should always reference the brand name so the manufacturer and batch could be identified if there were any problems with the medicine.

Ciclosporin – a medicine that suppresses the immune system (the body’s natural defence system). Different branded versions may cause different levels of ciclosporin in your blood.

Mesalazine – which is used to treat ulcerative colitis (a long-term condition that affects the colon). The way that mesalazine is absorbed varies between different brands.

Lithium – this treats a number of mental health conditions. Different brands vary widely in terms of how much of the medicine is absorbed and becomes active.

Beclometasone dipropionate CFC-free inhalers to treat asthma – there are two inhalers that contain the same active substance (beclometasone dipropionate), but one is much stronger.